Gambro AK200 ULTRA Hemodiafiltration Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-08-31

Brief Summary

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This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis.

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Detailed Description

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The AK200 ULTRA is a new device in the United States, but has been used for several years in Europe. The AK200 ULTRA is a single unit which is preprogrammed to provide standard hemodialysis as well as hemofiltration and hemodiafiltration with on-line preparation of the substitution fluid The AK200 ULTRA hemofiltration and hemodiafiltration is performed using a high flux membrane with high ultrafiltration rates compensated by volumetrically controlled infusion of on-line prepared substitution fluid. The AK200 ULTRA is, therefore, capable of providing dialysis treatments which can improve the removal of medium to high weight molecules without the difficulties associated with the manual measurement and administration of external substitution fluid.

This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis. This study is motivated by the need for a commercially available product capable of administering hemofiltration and hemodiafiltration in a clinical setting. The ultimate goal of this study is to improve morbidity and mortality in the ESRD patient population in the United States.

Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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On line hemofiafiltration

hemodiafiltration with the Gambro AK 200 ULTRA

Intervention Type DEVICE

On line hemodiafiltration

On line hemodiafiltration with the Gambro AK 200 ULTRA System

Intervention Type DEVICE

Other Intervention Names

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Gambro AK 200 ULTRA Gambro AK 200 ULTRA System

Eligibility Criteria

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Inclusion Criteria

1. Subject received chronic dialysis therapy
2. Subject was stable on three dialysis sessions per week
3. Subject was able to understand and sign the informed consent

Exclusion Criteria

) On chronic renal replacement therapy for less than three (3) months 2) Hospitalization for reasons other than vascular access complications in the past three (3) months 3) HIV + 4) Hepatitis B+ 5) Pregnancy, verified by pregnancy test for women of child bearing potential 6) Access recirculation \> 10% 7) Hematocrit less than 26% 8) History of non compliance 9) Pediatric patients, defined as less than 18 years old

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No